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Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

Primary Purpose

Cerebral Palsy, Bilateral Cerebral Palsy, Diplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
load modulation
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cerebral Palsy focused on measuring Cerebral Palsy, Bilateral Cerebral Palsy, Gait, Stepping, Stairs, Biomechanics, Neuroscience

Eligibility Criteria

5 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged 5 years to 19 years
  • typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs
  • ability to independently step up, with or without assistive devices.

Exclusion Criteria:

  • lower limb surgery in the past year
  • botulinum toxin injections to the lower limb muscles in the past 6 months
  • cognitive dysfunction that would make following directions difficult
  • comorbidities that would make participation unsafe.

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

load modulation

Arm Description

Participants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness.

Outcomes

Primary Outcome Measures

Joint biomechanics (support moment)
Sum of the joint kinetics from the hip, knee and ankle, termed the "support moment" and measured in Nm.
Joint biomechanics (hip)
hip torque (measured in Nm) will be identified for the hip, knee, and ankle during the duration of the task.
Joint biomechanics (knee)
Knee angle (between the thigh and shank measured in degrees) will be identified during the duration of the task.
Joint biomechanics (ankle)
Ankle angle (between the shank and foot measured in degrees) will be identified during the duration of the task.

Secondary Outcome Measures

Muscle activations (hip)
EMG data will be identified for underlying muscles of the hip during the stance phases of the task.
Muscle activations (knee)
EMG data will be identified for underlying muscles of the knee during the stance phases of the task.
Muscle activations (ankle)
EMG data will be identified for underlying muscles of the ankle during the stance phases of the task.

Full Information

First Posted
June 28, 2021
Last Updated
February 8, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04957277
Brief Title
Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
Official Title
Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate lower limb impairments in children with bilateral cerebral palsy during stepping tasks.
Detailed Description
Individuals with bilateral cerebral palsy (BCP) sustain a neonatal brain injury that leads to altered neuromuscular control to the lower limbs. One commonly observed motor impairment from this altered control is loss of selective voluntary motor control (SVMC), defined as the ability to independently move the joints intentionally. Loss of SVMC typically manifests as knee and ankle joint impairment and abnormal coupling between the hip adductors and lower limb extensors. This can make stepping up or down a curb or stair challenging, but quantitative investigation in these closed-chain activities has been limited. This is especially important as performance in stair-climbing is associated with limitations to overall mobility and community participation in cerebral palsy. The overall aim of this proposal is to investigate the altered neuromuscular control that challenges stair walking in individuals with BCP. Participants who consent to the study will be instructed to perform multiple step-ups and step-downs on a single raised platform. The parameters of the stepping task may change by adding weight to the body or subtracting weight from the body. Using standard gait analysis techniques, biomechanical metrics such as joint kinematics and kinetics will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Bilateral Cerebral Palsy, Diplegic Cerebral Palsy
Keywords
Cerebral Palsy, Bilateral Cerebral Palsy, Gait, Stepping, Stairs, Biomechanics, Neuroscience

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants are exposed to all conditions in a randomized order.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
load modulation
Arm Type
Experimental
Arm Description
Participants will experience different body weight loading conditions - with body weight added by a weighted vest or removed using the ZeroG overhead harness.
Intervention Type
Other
Intervention Name(s)
load modulation
Intervention Description
Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW
Primary Outcome Measure Information:
Title
Joint biomechanics (support moment)
Description
Sum of the joint kinetics from the hip, knee and ankle, termed the "support moment" and measured in Nm.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Title
Joint biomechanics (hip)
Description
hip torque (measured in Nm) will be identified for the hip, knee, and ankle during the duration of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Title
Joint biomechanics (knee)
Description
Knee angle (between the thigh and shank measured in degrees) will be identified during the duration of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Title
Joint biomechanics (ankle)
Description
Ankle angle (between the shank and foot measured in degrees) will be identified during the duration of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Secondary Outcome Measure Information:
Title
Muscle activations (hip)
Description
EMG data will be identified for underlying muscles of the hip during the stance phases of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Title
Muscle activations (knee)
Description
EMG data will be identified for underlying muscles of the knee during the stance phases of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.
Title
Muscle activations (ankle)
Description
EMG data will be identified for underlying muscles of the ankle during the stance phases of the task.
Time Frame
At baseline and each loading level; During entirety of the stepping trial, from initial lift-off to final contact onto the single platform.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 5 years to 19 years typically developing with no diagnosed medical conditions that affect movement, OR with a diagnosis of bilateral cerebral palsy (including diplegia, tetraplegia, and quadriplegia) where the lower limbs are more affected than the upper limbs ability to independently step up, with or without assistive devices. Exclusion Criteria: lower limb surgery in the past year botulinum toxin injections to the lower limb muscles in the past 6 months cognitive dysfunction that would make following directions difficult comorbidities that would make participation unsafe.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Theresa S Moulton, PT, DPT, PhD
Phone
3125033342
Email
theresa-moulton@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Moulton, PT, DPT, PhD
Phone
312-503-3342
Email
theresa-moulton@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw data files underlying publications will be shared
IPD Sharing Time Frame
Upon publication
IPD Sharing URL
https://arch.library.northwestern.edu/?locale=en
Citations:
PubMed Identifier
19627331
Citation
Rose J. Selective motor control in spastic cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):578-9. doi: 10.1111/j.1469-8749.2009.03401.x. No abstract available.
Results Reference
background
PubMed Identifier
20089048
Citation
Fowler EG, Staudt LA, Greenberg MB. Lower-extremity selective voluntary motor control in patients with spastic cerebral palsy: increased distal motor impairment. Dev Med Child Neurol. 2010 Mar;52(3):264-9. doi: 10.1111/j.1469-8749.2009.03586.x.
Results Reference
background
PubMed Identifier
21036615
Citation
Novak AC, Brouwer B. Sagittal and frontal lower limb joint moments during stair ascent and descent in young and older adults. Gait Posture. 2011 Jan;33(1):54-60. doi: 10.1016/j.gaitpost.2010.09.024. Epub 2010 Oct 30.
Results Reference
background
PubMed Identifier
9597060
Citation
Lepage C, Noreau L, Bernard PM. Association between characteristics of locomotion and accomplishment of life habits in children with cerebral palsy. Phys Ther. 1998 May;78(5):458-69. doi: 10.1093/ptj/78.5.458.
Results Reference
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Stepping to Understand Lower Limb Impairments in Bilateral Cerebral Palsy

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